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BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients

ConditionMetastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group

About this trial

This study was design to:

* To assess the impact of a biweekly (experimental arm) compared to a conventional administration (control arm) on the rate of grade 3-4 neutropenia in metastatic colorectal cancer (mCRC) patients treated with trifluridine/tipiracil plus bevacizumab, and * To identify predictive clinical and biological factors for grade 3-4 neutropenia in this patient population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and dated informed consent,

Patients willing and able to comply with protocol requirements,

Age ≥ 18 years,

ECOG PS 0-1,

Disqualifiers

ECOG PS 2,

Medical history or evidence of CNS metastasis upon physical examination, unless adequately treated (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, patients are stable without evidence of progression for at least 28 days prior to inclusion),

Local or locally advanced disease (stage I to III),

Concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trifluridine/tipiracil

    Drug

    35 mg/m², orally

  • Bevacizumab

    Drug

    5 mg/kg, intravenous route

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Arm A (experimental) - Trifluridine/tipiracil plus bevacizumab biweekly administrationExperimental treatment 2 interventions
Group B: Arm B (control) - Trifluridine/tipiracil plus bevacizumab conventional administrationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The occurrence of at least one grade 3-4 neutropenia

The occurrence of 3-4 neutropenia in mCRC patients undergoing treatment with the combination of bevacizumab and bi-weekly administration of trifluridine/tipiracil (experimental arm) compared to a conventional administration (control arm).

Time frame
From randomization up to 14 days after the end of treatment

Secondary outcomes

1

Overall survival (OS)

OS in both arms; calculated from the date of randomization to the date of death from any cause.

Time frame
From the date of randomization to the date of death from any cause, assessed up to 3 years
2

Progression-free survival (PFS)

PFS in both arms; defined as the time from randomization to the date of the first documented PD determined by the Investigator assessment by RECIST 1.1 or death due to any cause, whichever occurs first

Time frame
From randomization to the date of the first documented disease progression or death due to any cause, up to 3 years
3

Best overall response (BOR)

BOR according to Response Evaluation Criteria Solid Tumors (RECIST) v1.1 in both arms; defined as the best response designation (CR, PR, SD or PD), evaluated on all radiological evaluations available and related to study treatment period.

Time frame
From randomization to the date of progression, death or subsequent anti-cancer therapy, up to 3 years
4

Disease control rate (DCR)

DCR in both arms according to RECIST v1.1; defined as at least a CR, PR or SD radiological evaluation designation on all radiological evaluations available and related to study treatment period.

Time frame
Up to achievement of best overall response (BOR) of CR or PR or SD, up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GERCOR - Multidisciplinary Oncology Cooperative Group

Lead sponsor

Servier

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: